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Author
Topic: START or not start? (Read 9551 times)

Thing is, my doc offered me to be part of the START study, meaning I would start meds early. So this month I went to the research center, they talked to me about it, ran some tests, and I am indeed eligible. They gave me the terms of consent to read and think about it, and here I am.

My situation is: I've been infected for a year and a half. Through all this time, my CD4 has oscilated from 700 to 600, the highest being 734, and the lowest, 601 (this last one). Stable, I guess.

Viral load pretty much stable too, going from 40.000 to 20.000, last one being 26.000.

In the guidelines here, I would possibly wait a few years until I start treatment, since I would have to wait until my CD4 goes under 350.

So I ask: which do you think it's better, in terms of benefits for me? Do I start now or wait until it's time?

If I decide to participate, it's not certain I will start taking meds, it's a 50/50 chance, because I may end up in the control group. Also, I would basically start with Atripla (EFV + Truvada).

So I ask: which do you think it's better, in terms of benefits for me? Do I start now or wait until it's time?

well considering that those are the questions the START study is supposed to answer, I doubt we can really tell you the best choice - at least not until you and others take part in this study and help them determine the answers. LOL

however, the best way to make any decision is to look at the four sides of it:1) the pros of joining the study2) the cons of joining the study3) the pros of not joining the study4) the cons of not joining the study

I'll start you off by listing reasons for #1 you'll eventually need meds, so why not start early why not start early to prevent your immune system from being damaged much at all why not take advantage of the great access to meds and healthcare provided through the study long term effects happen to fewer than 10% so it's not like starting early should cause too many more problems. I know the study is supposed to determine this; but this is the most likely outcome, so play the odds and help others have better health when the outcome if revealed that the early start is the way to go.

My first late long-term partner was in several clinical trials until he was just too sick to be of any use. I started meds in the early 90s and often had to wait until something new came to the market. I feel like I've often been a guinea pig and in some sort of study taking 4 azt pills every 4 hours 7-days a week or taking 8 tablespoons of liquid norvir a day or being one of the first patients to use Sustiva. Having done stuff like that, I think that with today's awesome regimens of HAART taking part in this study is a no-brainer.

best wishes to you on however you decide.

Logged

leatherman (aka mIkIE)

All the stars are flashing high above the seaand the party is on fire around you and meWe're gonna burn this disco down before the morning comes- Pet Shop Boys chart from 1992-2015Isentress/Prezcobix

For research purposes and future HIVers. It would make me feel good about myself doing something for a good cause.

Well, it doesn't really help research or anything, I'm not testing a new drug. I'm trying to reflect about it in a more selfish perspective: the benefits for me, what they would be. But I see your point.

well considering that those are the questions the START study is supposed to answer, I doubt we can really tell you the best choice - at least not until you and others take part in this study and help them determine the answers. LOL

I know, don't worry, I'm not looking for the perfect answer or the perfect way to go, but I deeply respect and consider in high regard the opinion of many of you all.

why not take advantage of the great access to meds and healthcare provided through the study

Also taking into consideration the other points you said, about this one, there is the benefit of using Truvada, which is not currently available here. If I would start treatment today, it would be EFV+3TC+TDF. So the benefit is taking less pills, and FTC instead of 3TC. The problem is that I would receive Truvada only until the end of the study (and 6 months more), so I would probably have to change meds then. The healthcare is unchanged, no difference there, except I can sue them if something happens to me because of the study, LOL. And it's kinda funny for the American govt to be paying for my meds.

glancing through your 380-something posts , I didn't really see; but are you in/from Brazil?why would you have to change back off the truvada? is that a guess or a certainty? would your doc/coverage not be able to keep you on that med?

Logged

leatherman (aka mIkIE)

All the stars are flashing high above the seaand the party is on fire around you and meWe're gonna burn this disco down before the morning comes- Pet Shop Boys chart from 1992-2015Isentress/Prezcobix

According to this thread from March 2012 your CD4 %age (as opposed to absolute counts) was quite low- as low as 16%, 17%, 16% on the last three exams. I think that in itself is a good reason to start meds early, for 16% seems precariously close to the 12-15% region and even though your absolute CD4 count is >500 and thus nowhere near 'very immuno-compromised danger zone', your percentage isn't as comforting.

Moreover, I can't think of a logical reason to not partake in the START trials- either in the treatment naive limb or in the early treatment limb.

I wanted to participate in this study myself but couldn't since there are no hospitals in my city participating in the study.

How do you feel, physically? I know that isn't always a good indicator, as people with very, very low CD4's report feeling great, before they got really ill. But, you know you're not in that situation.

I just wanted to wish you the best in making the decision. If you feel you're being rushed into a decision due to a deadline to participate, you should consider putting off the decision for now. I know everyone would want a patient to be mentally ready to start and prepared to be adherent.

I am dense. If someone decides that they WANT to start HAART, then start HAART. Why go into a study that has a 50% chance of not providing the treatment, and being a control. Participating in the study seems more to suit people who don't care much about starting or not starting, but don't mind helping out science.

Logged

“From each, according to his ability; to each, according to his need” 1875 K Marx

if its true your CD4% is low as what has been mentioned above, ie approx 16%, I was under the impresssion that you should be considering commencing meds now....as the CD4% trend over time is a more accurate measure of your immune system compared to the variable fluctuating CD4 absolute count.

If cost is not a factor in this decision, and you have only your self interest in mind, why therefore would you want to risk going on a trial with a 50% chance of not starting on meds?

I'm not American, and I don't live in the US. In my country, like in most places, I can only start meds when my CD4 goes under 350 (or I get an opportunistic infection). The government here provides the meds for free, but there is this requirement. If I wanted to start treatment today, I wouldn't be allowed to. Only through participating in START I would take meds now. That's why.

Oh, and while CD4% is not taken into consideration for treatment guidelines by most standards, mine is back to 20% anyway.

glancing through your 380-something posts , I didn't really see; but are you in/from Brazil?why would you have to change back off the truvada? is that a guess or a certainty? would your doc/coverage not be able to keep you on that med?

Yup, land of sunny beaches and beautiful women (and men).

Like I said above, the govt provides all the meds for free and I can't buy meds (unless I import, but you know how expensive they are). And Truvada is not yet available here. So it's likely that I would have to change Truvada when the study is over. Unless, by the time it's over, the govt introduces Truvada as well over here. It's possible, but difficult to say.

I wanted to participate in this study myself but couldn't since there are no hospitals in my city participating in the study.

You have too good of a memory, lol. Yeah, my CD4% was not great, but doc wasn't worried about it, and now it went up, like I said above. But anyway, I am wondering: with your numbers, why did you want to participate in this study? What are your reasons?

How do you feel, physically? I know that isn't always a good indicator, as people with very, very low CD4's report feeling great, before they got really ill. But, you know you're not in that situation.

Thanks for your best wishes, tednlou2. I do feel healthy, except from a bout of shingles a few months ago. The health problems that are bothering me now are warts and ulcerative colitis, but they don't really have any connection to HIV. So apart from that, all good.

I'm not American, and I don't live in the US. In my country, like in most places, I can only start meds when my CD4 goes under 350 (or I get an opportunistic infection). The government here provides the meds for free, but there is this requirement. If I wanted to start treatment today, I wouldn't be allowed to. Only through participating in START I would take meds now. That's why.

Oh, and while CD4% is not taken into consideration for treatment guidelines by most standards, mine is back to 20% anyway.

So unless you meet the treatment requirements established by the authorities where you live you can't get HAART?

All of my 14 mediations are free, but for some reason all of the foreigners here keep telling me that US healthcare sucks chunks. And you know we don't have to wait for some COMMUNIST GUBMENT BUREAUKKKRAT to tell us we have to be at "x" cd4 count to pop our pills.

All of my 14 mediations are free, but for some reason all of the foreigners here keep telling me that US healthcare sucks chunks. And you know we don't have to wait for some COMMUNIST GUBMENT BUREAUKKKRAT to tell us we have to be at "x" cd4 count to pop our pills.

Fuck, are you still alive?

I thought we'd wrapped your emaciated carcass in a cheap rug and left you to rot in In Memoriam some time back in April.

All I would like is opinions regarding the pros and cons of starting treatment now or to wait, and what you would do if you were in my place. It's an important decision I have to make and I would like to hear different points of view. That's all.

But anyway, I am wondering: with your numbers, why did you want to participate in this study? What are your reasons?

I wanted to participate in the study irrespective of whether I choose to go on treatment early or wait until later. I think it is a win-win situation-cos eitherway the results would be useful in arriving at a more grounded answer to the eternal question: When to start? But I live in North India and the only hospitals participating in this global study are in Western and Southern India, so not possible for me. Sadly.

chance of being wrecked by CNS issues? Gee, thanks for the encouragement.

I'm just saying it's something that you should consider, that's all. Such as if you do elect to go into this trial, and you get put on Atripla, what happens if you have to discontinue the medication because of this very well known side effect? What do they put you on after that? It's simply the reality, and since you live in Brazil I don't know the answer to my question, hence it's hard for me to recommend going into the trial.

I'm just saying it's something that you should consider, that's all. Such as if you do elect to go into this trial, and you get put on Atripla, what happens if you have to discontinue the medication because of this very well known side effect? What do they put you on after that? It's simply the reality, and since you live in Brazil I don't know the answer to my question, hence it's hard for me to recommend going into the trial.

Sorry if you don't like my answer, just being honest with you.

Nah, it's ok. If it doesn't work, it would probably be Reyataz/Norvir + Truvada. Or Lexiva. If that doesn't work well either, then there's a slight chance of getting Isentress.

Well, it doesn't really help research or anything, I'm not testing a new drug. I'm trying to reflect about it in a more selfish perspective: the benefits for me, what they would be. But I see your point.

Hiya LM,

I disagree -- it does (or would) help research that is why they call it a research study. Studies are not always about testing a new drug. In terms of the benefits for you, yes, there's a chance you could start meds early. As Miss P advised, you best bone up on Atripla so you know if you're randomized to it what you may experience. If eligible, educated, and interested, I would go for it were I you.

To date, I've only enrolled in HIV-related studies with no direct benefits and hope that someday I get an opportunity to be in one that does have direct benefits.

I disagree -- it does (or would) help research that is why they call it a research study. Studies are not always about testing a new drug. In terms of the benefits for you, yes, there's a chance you could start meds early. As Miss P advised, you best bone up on Atripla so you know if you're randomized to it what you may experience. If eligible, educated, and interested, I would go for it were I you.

To date, I've only enrolled in HIV-related studies with no direct benefits and hope that someday I get an opportunity to be in one that does have direct benefits.

Em

I suppose you're right. I do think participating in research to help others is a good thing, I do consider that. I just want to take that off the equation for a moment to think of personal benefits in starting treatment early or not.

I'm aware of the possible side effects of Atripla, and from I gathered here, some people do great on it, others not so much, mainly because of mood issues (and if anyone that has used Atripla and could share their experience, I would gladly appreciate it). But let's see.

Did you ask anyone in the know when Sustiva+Truvada, or Atripla, will be on the free meds list in Brazil? How long will you be in the study if you do it?

Basically, if you want to be on HAART now, do the study and take your 50-50 chance. Since that is better than 0 chance of getting meds now, if you don't start the study.

No one knows for sure. It's likely that at least Truvada will be introduced in the next few years, especially if there's a price drop.

If I participate in the study, the doc said I would be in it for at least 1 year and a half. The terms of consent say around 3 years. So, like I said, if there is no Truvada here after that, I would be put on lamivudine and tenofovir instead.

But that's the issue, I don't know if it's a good idea to go on HAART now. That's why I'm gathering opinions to decide if it's a good idea for me, if there are more benefits for my health to start early.

But that's the issue, I don't know if it's a good idea to go on HAART now. That's why I'm gathering opinions to decide if it's a good idea for me, if there are more benefits for my health to start early.

Well now -- if there was consensus on starting early, there wouldn't be this study, would there? I think what you are looking for is the answer the study hopes to drive toward in order to decide if you should take part in the study. A bit circular -- or backwards, depending on your view......

I'll give you my opinion, but that doesn't mean that it is a good idea for you -- really, anyone's opinion is pretty useless in the big picture here. But, as it is what you want, here goes......... If I were you, I would join, in order to start meds early. That opinion is only based on your inability to start now any other way -- if you lived in a different country, with other options -- I would NOT do the study, because I'd want to know I'd be on the meds.

BTW -- I've had no real issues with Atripla -- some dreams -- more vivid the first month or so, but still get them almost 7 years later. I don't mind them.

In fact, the dreams are usually enjoyable, certainly a bit trippy. It is a bit unusual to wake up and realize you have had one of those unique Atripla dreams. Like Bocker, I have been using Atripla for almost six years and have absolutely no problems at all. Best of luck

But that's the issue, I don't know if it's a good idea to go on HAART now. That's why I'm gathering opinions to decide if it's a good idea for me, if there are more benefits for my health to start early.

Your dilemma is precisely why the START study is being conducted.

Here’s a link that delineates the benefits and limitations of early initiation of HAART. (i.e. CD4>500).

Patients with CD4 counts >500 cells/mm3 The NA-ACCORD study also observed patients who started ART at CD4 counts >500 cells/mm3 or after CD4 counts dropped below this threshold. The adjusted mortality rates were significantly higher in the 6,935 patients who deferred therapy until their CD4 counts fell to <500 cells/mm3 than in the 2,200 patients who started therapy at CD4 count >500 cells/mm3 (risk ratio: 1.94, 95% CI: 1.37–2.79) [11]. Although large and generally representative of the HIV-infected patients in care in the United States, the study has several limitations, including the small number of deaths and the potential for unmeasured confounders that might have influenced outcomes independent of ART.

In contrast, results from 2 cohort studies did not identify a benefit of earlier initiation of therapy in reducing AIDS progression or death. In an analysis of the ART-CC cohort [6], the rate of progression to AIDS/death associated with deferral of therapy until CD4 count in the the 351 to 450 cells/mm3 range was similar to the rate with initiation of therapy with CD4 count in the 451 to 550 cells/mm3 range (HR: 0.99, 95% CI: 0.76–1.29). There was no significant difference in rate of death identified (HR: 0.93, 95% CI: 0.60–1.44). This study also found that the proportion of patients with CD4 counts between 451 and 550 cells/mm3 who would progress to AIDS or death before having a CD4 count <450 cells/mm3 was low (1.6%; 95% CI: 1.1%–2.1%). In the CASCADE Collaboration [12], among the 5,162 patients with CD4 counts in the 500 to 799 cells/mm3 range, compared with patients who deferred therapy, those who started ART immediately did not experience a significant reduction in the composite outcome of progression to AIDS/death (HR: 1.10, 95% CI: 0.67–1.79) or death (HR: 1.02, 95% CI: 0.49–2.12).

With a better understanding of the pathogenesis of HIV infection, the growing awareness that untreated HIV infection increases the risk of many non-AIDS-defining diseases (as discussed below), and the benefit of ART in reducing transmission of HIV, the Panel also recommends initiation of ART in patients with CD4 counts >500 cells/mm3 (BIII). However, in making this recommendation the Panel notes that the amount of data supporting earlier initiation of therapy decreases as the CD4 count increases to >500 cells/mm3 and that concerns remain over the unknown overall benefit, long-term risks, and cumulative additional costs associated with earlier treatment.

When discussing starting ART at high CD4 cell counts (>500 cells/mm3), clinicians should inform patients that data on the clinical benefit of starting treatment at such levels are not conclusive, especially for patients with very high CD4 counts. The same is true for individuals with low viral load set points at presentation and for “elite controllers”. Further ongoing research (both randomized clinical trials and cohort studies) to assess the short- and long-term clinical and public health benefits and cost effectiveness of starting therapy at higher CD4 counts is needed. Findings from such research will provide the Panel with guidance to make future recommendations.

I'll give you my opinion, but that doesn't mean that it is a good idea for you -- really, anyone's opinion is pretty useless in the big picture here. But, as it is what you want, here goes......... If I were you, I would join, in order to start meds early. That opinion is only based on your inability to start now any other way -- if you lived in a different country, with other options -- I would NOT do the study, because I'd want to know I'd be on the meds.

In fact, the dreams are usually enjoyable, certainly a bit trippy. It is a bit unusual to wake up and realize you have had one of those unique Atripla dreams. Like Bocker, I have been using Atripla for almost six years and have absolutely no problems at all. Best of luck

Gary

Thanks for sharing your experience with Atripla. You and bocker. It's good to see that, because I know some people get in deep trouble, like the guy on another thread that got suicidal. Sca-ree.

Guys, I know there is no definite answer, that's why I said opinions, what you would do in my place. But thanks for the link, space.

And if I may ask, why would you start meds early?

Thanks for sharing your experience with Atripla. You and bocker. It's good to see that, because I know some people get in deep trouble, like the guy on another thread that got suicidal. Sca-ree.

I would start early. You see quite a bit of opinion and research that suggests starting early versus late is beneficial. You rarely see the opposite. Granted, much of it is opinion.

I've been on Atripla for a couple years and have no troubles with it. Atripla is the most prescribed HIV medication in the US. Most people do just fine. 10% give or take don't. It's not something I would be scared about, just informed about.

Because I see no reason to let a virus run unchecked when there are effective medicines available. Yes, I know we don't know what spending 25+ years on these meds will do to us. I still am of the mind that I'd rather deal with POSSIBLE long-term issues from the meds than having my body further ravaged by this virus. That is my opinion.For full disclosure -- I didn't really need to have this debate as my first two CD4 counts were 350 and 288 (a month apart), so there wasn't any question. Although, I am fairly confident I would have started pretty quick regardless.

I couldn't see the difference between taking meds the rest of my life or the rest of my life minus two years.

I didn't want the constant worry of going to the doc and waiting for labs to see what had happened.

I had high T-Cells at the time as I was just infected and wanted to keep them up there. At 46, I knew it would be a long climb back if my T-Cells got low.

Both my docs in San Francisco (UCSF) and Kaiser (Oakland) said it was a good idea. I have good docs and trust them.

I have good insurance -- meds cost me $105 a month.

I don't believe in the 350 cutoff (now 500 in US). One day I think the standard will be to treat as soon as you are infected.

I think the longer the virus is unchecked, the more damage it can do. Your immune system is under strain, give it all the help you can by protecting as much of it as you can.

I wanted to feel proactive -- I was actively managing my health, doing something good and positive for myself.

I would be much less infectious to others in the event of an accident.

I wanted to get undetectable and call that my "new normal" so I could begin to focus back on the important things in my life.

And finally, if a cure did come along, I wanted to be in as good a shape as possible to try it.

That was pretty much my thinking 3 years ago. I went on Reyataz / Truvada / Norvir (resistant to Atripla).

Results were that I got UD in about 12 weeks, T-Cells stayed good and stable (800ish).

Side effects were feeling "fuzzy" for two weeks when I started taking meds, an upset stomach which I take a probiotic for which works most of the time. I also get yellowing in the eyes and skin sometimes, but it's not that noticeable. I do get more tired than I used to, that could just be getting older, I'm not sure.

In my case I just started the generic of ATRIPLA (anyway, it is exactly the same), if I could have done it before, I would have taken it around 500. My number are above.

For now, after just one month, I noticed I have most energy and feel greater than without meds. Dizzyness has been for 2-3 weeks, only on the morning, and never avoid me to work or to do what I have to do (having great dinners...)

Also, I was very worried being without any treatment, worried about loosing my health (on the lasts month I started loosing weight)

In my opinion, if you feel ready to be adherent to the treatment and be able to take it every day, why should you wait... Consider it can bring you a lot of tranquility knowing that your HIV is controllated, in regard to short term side effects, the balance is really possitive, in regard to long term, I also think to, but have no personnal experience in regard with it...

Modified to add that another great and relevant fact is that the meds make you decrease the possibility to infect anyone else, it is also quite important for tranquility...

Personally, i would start just to stamp out the viral load. Good enough reason for me. Besides, you will need to start at some point or another so might as well get it over with and stop your anxiety of when to start.Besides, for the sake of research...id do it anyway.Good luck with your choice.

I would start treatment...Your CD4% is not great, your VL is moderate.Atripla is still the gold standard for treatment. The vast majority do not have serious CNS issues, effavirenz has a very long half life therefore forgiving as to schedule. Continued inflammation is considered a risk to ones health...limit it with meds.I started at 29% CD4 count and 511 4 years ago and have no regrets.

Just read some news that may give you a little more to think about. Well, I'm sure it will give you a lot to think about. Brazil is changing their guidelines for treatment and will now include anyone at 500 or below. So, you won't have to wait until 350 to start.

Just read some news that may give you a little more to think about. Well, I'm sure it will give you a lot to think about. Brazil is changing their guidelines for treatment and will now include anyone at 500 or below. So, you won't have to wait until 350 to start.

Hi tednlou2, just saw your message too, thank you. Yes, I read those news as well... and it actually confused things for me, because I think that, if I participate in the study and end up in the group that has to wait for treatment, I might have to wait until it reaches 350 anyway. At least that's what it says in the terms of consent. Next week I have an appointment with the doc at the research center and then I will ask about that.

Hi tednlou2, just saw your message too, thank you. Yes, I read those news as well... and it actually confused things for me, because I think that, if I participate in the study and end up in the group that has to wait for treatment, I might have to wait until it reaches 350 anyway. At least that's what it says in the terms of consent. Next week I have an appointment with the doc at the research center and then I will ask about that.

I am assuming that the language in the research papers is going by the old guidelines before this news happened. I suspect they will change that. Let us know what you find out.

There are programs with all the pharmaceutical companies to get co-pay assistance. You should be able to drop your $105 per month to zero. A BUNCH of us already have. For some reason, clinic staff and pharmacists are NOT getting the word out to the insured. Some companies actually go beyond HIV meds!(I'll find the link to the info and amend this post -- apologies for derailment to the OP)

I think there's at least one phone number that might be incorrect but the entity answering will refer you to the correct number -- it's either Gilead or Merck -- can't remember which one. It's a quick phone call to sign up, get your number and you can start this INSTANTLY with your pharmacist. They'll then have your number on file and you don't have to horse around with this each time. I do believe you have to sign up on a yearly basis as long as the programs are being provided. It is a godsend!

I've signed the papers and I'm (probably) on the study. Well, they have to confirm with another test that I still have CD4 over 500 to participate, and results should be back this week, but it shouldn't change in such a short time.

Also, since I have ulcerative colitis, I might have to start taking azathioprine soon, and they didn't know if that would be a problem for me to participate, but they said they would call the US to confirm and call me back if it wasn't possible, asap. That was over a week, so if they didn't call, I guess it's ok.

The problem is that, even though the guidelines here just changed to starting treatment when CD4 dips below 500, if I end up in the group that doesn't start meds, I'll still have to wait until it goes under 350.

So in a few weeks, if all is well, I should find out if I'm starting meds now or much later.